METADERM PSORIASIS BODY AND SCALP- achillea millefolium, aesculus hippocastanum, berberis vulgaris, conium maculatum, matricaria chamomilla, phytolacca decandra, rhus toxicodendron, sanguinaria canadensis spray 
Cosmetic Specialty Labs, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Metaderm Psoriasis Body and Scalp Spray

Active Ingredient

Achillea millefolium (3X H.P.U.S.*, 0.04%)
Aesculus hippocastanum (3X H.P.U.S.*, 0.04%)
Berberis vulgaris (3X H.P.U.S.*, 0.09%)
Conium maculatum (3X H.P.U.S.*, 0.21%)
Matricaria chamomilla (3X H.P.U.S.*, 0.05%)
Phytolacca decandra (3X H.P.U.S.*, 0.11%)
Rhus toxicodendron (3X H.P.U.S.*, 0.13%)
Sanguinaria canadensis (3X H.P.U.S.*, 0.08%)

Purpose

Cracking, Dryness, Rash, Scaling
Inflammation, itching
Burning, Itching, Redness, Scaling
Burning, Itching, Inflammation
Redness, Itching
Inflammation, Itching, Redness
Bleeding, Redness
Dryness, Irritation, Itching

*The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Uses:

Fights recurrence of flaking, scaling, itching, redness, and skin
irritation associated with psoriasis

Warnings:

for external use only

Consult your doctor before using this product if the condition covers a
large area of the body

When using this product:

Stop use and ask a doctor if:

condition worsens or does not improve after
regular use as directed.

Keep out of reach of children.

If swallowed, get medical help or
contact a Poison Control Center immediately. Test for allergy by
rubbing a small amount on skin first. Do not use if allergic to or
hypersensitive to any ingredient.

Directions:

For scalp, part hair, hold targeted nozzle no more than 1 inch from scalp, and spray at the roots to cover the affected area. For body, hold nozzle about 6 inches from skin and spray to cover the affected area. Lightly massage into scalp or skin with fingertips, No rinsing. Repeat on all affected areas and style hair as usual. Apply liberally to dry or wet skin 2 times daily.

Other ingredients:

Purified Water, Glycerin, Niacinamide, Phenoxyethanol,

1,2-Hexanediol, Caprylyl Glycol, Acrylates-C10-30 Alkyl

Acrylate Crosspolymer, Aminomethyl Propanol, Sodium Citrate,

Polysorbate-20, Citric Acid, Hamamelis virginiana, Hydrastis canadensis,

Avena sativa, Populus alba, Populus tremuloides, Cochlearia ocinalis,

Ervum lens, Scrophularia nodosa, Veronica ocinalis, Althaea ocinalis,

Sambucus nigra, Malva sylvestris, Nasturtium ocinale, Smilax medica,

Tussilago farfara, Pimpinella saxifraga, Vincetoxicum ocinale.

Principal Display Panel and Drug Facts

PDPDG4

METADERM PSORIASIS BODY AND SCALP 
achillea millefolium, aesculus hippocastanum, berberis vulgaris, conium maculatum, matricaria chamomilla, phytolacca decandra, rhus toxicodendron, sanguinaria canadensis spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-391
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER) (MATRICARIA CHAMOMILLA FLOWERING TOP OIL - UNII:SA8AR2W4ER) MATRICARIA CHAMOMILLA FLOWERING TOP OIL5 [hp_M]  in 1 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT8 [hp_M]  in 1 mL
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK) (ACHILLEA MILLEFOLIUM - UNII:2FXJ6SW4PK) ACHILLEA MILLEFOLIUM4 [hp_M]  in 1 mL
BERBERIS VULGARIS FRUIT (UNII: 6XEF22AHC3) (BERBERIS VULGARIS FRUIT - UNII:6XEF22AHC3) BERBERIS VULGARIS FRUIT9 [hp_M]  in 1 mL
CONIUM MACULATUM FRUIT (UNII: Y71WKJ3A2K) (CONIUM MACULATUM FRUIT - UNII:Y71WKJ3A2K) CONIUM MACULATUM FRUIT21 [hp_M]  in 1 mL
RHUS SPP. WHOLE (UNII: 3U7FG9T9MW) (RHUS SPP. WHOLE - UNII:3U7FG9T9MW) RHUS SPP. WHOLE13 [hp_M]  in 1 mL
PHYTOLACCA OCTANDRA LEAF (UNII: 0804KD28Q9) (PHYTOLACCA OCTANDRA LEAF - UNII:0804KD28Q9) PHYTOLACCA OCTANDRA LEAF110 [hp_M]  in 1 mL
AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y) (AESCULUS HIPPOCASTANUM SEED OIL - UNII:E0M52HIR1Y) AESCULUS HIPPOCASTANUM SEED OIL4 [hp_M]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
VERONICA OFFICINALIS LEAF (UNII: 96R87REA55)  
ALTHAEA OFFICINALIS LEAF (UNII: E2QQV92338)  
SCROPHULARIA NODOSA (UNII: 7H443NUB2T)  
WATER (UNII: 059QF0KO0R)  
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HYDRASTIS CANADENSIS WHOLE (UNII: R763EBH88T)  
TUSSILAGO FARFARA (UNII: 0JXZ63016V)  
LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)  
SAMBUCUS NIGRA FLOWER OIL (UNII: Q35633V53D)  
MALVA SYLVESTRIS LEAF (UNII: 17H39B00T5)  
NIACINAMIDE (UNII: 25X51I8RD4)  
AVENA SATIVA LEAF (UNII: 206PI19V7R)  
POPULUS TREMULOIDES LEAF (UNII: 7IIH57D9E0)  
POPULUS ALBA LEAF (UNII: A74CT64437)  
COCHLEARIA OFFICINALIS LEAF (UNII: WAG1VW36J6)  
SARSAPARILLA (UNII: 2H1576D5WG)  
NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
VINCETOXICUM ATRATUM ROOT (UNII: 7DQZ24B35Y)  
PIMPINELLA SAXIFRAGA ROOT (UNII: 5Y05905N7G)  
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58133-391-32950 mL in 1 BOTTLE; Type 0: Not a Combination Product08/15/2018
2NDC:58133-391-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/15/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/15/2018
Labeler - Cosmetic Specialty Labs, Inc. (032973000)
Registrant - Cosmetic Specialty Labs, Inc. (032973000)
Establishment
NameAddressID/FEIBusiness Operations
Cosmetic Specialty Labs, Inc.032973000manufacture(58133-391)

Revised: 8/2018
Document Id: 7391b53f-5566-1f45-e053-2991aa0a4fce
Set id: 7391b53f-5565-1f45-e053-2991aa0a4fce
Version: 1
Effective Time: 20180816
 
Cosmetic Specialty Labs, Inc.